Thought Leadership

Thought Leadership

Analytical Development

Overview Pharmaceutical and healthcare products require detailed analysis — chemically, biochemically, and preclinical assessments — as part of the licence submission package to assure...

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Thought Leadership

Flexible Resourcing

Woodley BioReg has been resourcing projects for over 20 years, providing specialist regulatory, quality, and project management consulting services to the increasingly competitive and...

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Thought Leadership

Pharmacovigilance xEVMPD/QPPV

Overview All Marketing Authorisation Holders (MAHs) for any medicinal product authorised or registered within the EU and UK must submit information relating to the...

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Thought Leadership

Method Scouting

What is method scouting? Method scouting is the term used to describe the assessment of potential test methods during the early stages of product...

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Thought Leadership

Drug or Device Discovery

What is drug discovery? The pharmaceutical industry includes products borne out of drug discovery programmes, extensions to existing product lines, longstanding brand lines and...

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Thought Leadership

Import Services

The European Boards of Health (BOH) seek to ensure that any licensed medicinal products brought into the EU by non-EU manufacturers meet EU law...

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Thought Leadership

Agency Meetings

Overview The long and costly development process for the development of new pharmaceuticals places huge commercial pressures on companies to secure Marketing Authorisations in...

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Thought Leadership

Project Management

Overview Successful programme and project management of biopharmaceutical,  pharmaceutical, healthcare, over-the-counter (OTC), and medical device products requires a unique blend of technical, scientific, regulatory, and quality skills to ensure...

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Thought Leadership

License Variations

Overview Licence variations record the changes in methods of manufacture and testing that deviate from the originally approved methods and procedures. This approval can...

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